OP-FIX-Band
by GERWING Medizinprodukte Gerd Riester e.K. 17 variants
Ref GE 01-36x8 WV, GE 01-30x5 FIM, GE 01-80x5, GE 01-28x3 FV, GE 01-40x5, GE 01-40x5 WVS, GE 01-30x5, GE 01-30x5 N, GE 01-40x5 N, GE 01-28x3, GE 01-40x5 FI, GE 01-30x5 NFI, GE 01-80x5 FI, GE 01-80x5 FV, GE 01-40x5 FV, GE 01-42x5 FIG, GE 09-32x5 GModel Patientenhalter
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426046972GE0174 | Date22 Oct 2021 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Patientenhalter, GE 01-36x8 WV, GE 01-30x5 FIM, GE 01-80x5, GE 01-28x3 FV, GE 01-40x5, GE 01-40x5 WVS, GE 01-30x5, GE 01-30x5 N, GE 01-40x5 N, GE 01-28x3, GE 01-40x5 FI, GE 01-30x5 NFI, GE 01-80x5 FI, GE 01-80x5 FV, GE 01-40x5 FV, GE 01-42x5 FIG, GE 09-32x5 G
- Primary DI / UDI-DI
- 04260469720222, 04260469720154, 04260469720338, 04260469720079, 04260469720239, 04260469720291, 04260469720123, 04260469720161, 04260469720260, 04260469720062, 04260469720253, 04260469720178, 04260469720352, 04260469720345, 04260469720246, 04260469721250, 04260469721045
- Basic UDI-DI
- 426046972GE0174
- Direct Marketing DI
- 0426046972022204260469720154042604697203380426046972007904260469720239042604697202910426046972012304260469720161042604697202600426046972006204260469720253042604697201780426046972035204260469720345042604697202460426046972125004260469721045
- EMDN Code
- V80 Clinical use accessories not included in other classes
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006156
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No